Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

The UPDRS is designed to monitor disability and impairment due to Parkinson's disease. It comprises several parts. Part I evaluates "Mentation, Behavior, and Mood" (with a maximum of 16 points; more points are worse); Part II evaluates "Activities of Daily Living" (with a maximum of 52 points); Part III entails a "Motor Examination" (with a maximum of 108 points). Total score of Parts I-III sums the points from all parts and thus can range from a minimum of 0 (best) to a maximum of 176 (worst).

[2]

The MoCA assesses short term and working memory, visual-spatial abilities, executive function, attention, concentration, language and orientation. The total score ranges from 0 to 30 (highest function).

[3]

GDS-S is a short 15 'yes/no' question instrument for assessing depression in older adults. Questions are answered by the research participant (i.e., self-rater). Scores range range from 0 to 15 and higher scores represent greater depression. Scores of 5-9 and >9 have been correlated with mild and moderate-severe depression, respectively.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

[A:]Placebo

Placebo to produce no urate elevation

[B:]Mild

Inosine to produce a mild urate elevation

[C.]Moderate

Inosine to produce a moderate urate elevation

Measured Values

[A:]Placebo

[B:]Mild

[C.]Moderate

Number of Participants Analyzed
[units: participants]

16

16

17

Change in Serum Urate
[units: mg/dL]Mean (Standard Deviation)

-0.07
(0.43)

2.49
(1.07)

3.26
(1.25)

No statistical analysis provided for Change in Serum Urate

36. Secondary:

Change in Serum Urate [ Time Frame: Visit 11 from Baseline (i.e., between -45 days and +21 months) ]